Abstract 97P
Background
Pulmonary adenocarcinoma with high-risk pathological factors are known to be associated with poor prognosis in early-stage non-small-cell lung cancer (NSCLC). Aumolertinib is a third-generation EGFR-TKI that has efficacy in EGFR sensitive and resistant NSCLC. The efficacy of aumolertinib as adjuvant therapy in resected stage I–III NSCLC with high-risk pathological factors remains unknown.
Methods
Patients underwent completely resected pathologic stage I–III lung adenocarcinoma with micropapillary/solid component with or without complex glands were enrolled. Patients were assigned to aumolertinib group (group A): patients with EGFR mutation-positive (exon 19 deletion or L858R) received aumolertinib (110 mg daily), group B (EGFR mutation positive) and group C (EGFR mutation negative or unknown). Both group B and C received observation for disease recurrence and no adjuvant therapy was given. The primary endpoint was investigator assessed disease-free survival (DFS) and safety was evaluated.
Results
A total of 115 stage I–III lung adenocarcinoma with micropapillary or solid component patients were enrolled. 70 patients were EGFR mutation-positive (45 in aumolertinib group, 25 in group B). 45 patients were EGFR mutation-negative or unknown and assigned to group C. At data cut-off, all patients in aumolertinib group have no symptoms of tumor recurrence and continued aumolertinib, the 1-year DFS was 100%. In group B, 64% patients were alive and disease-free, 3 of 25 patients had tumor recurrence within 1 year (1-year DFS: 88%). In group C, 89% patients were alive and disease-free, 1-year DFS was 93%. Compared two no EGFR-TKI treatment groups, the recurrent ratio in EGFR mutated patients was higher than EGFR negative or unknown group. There were no grade ≥3 adverse events occurred during aumolertinib treatment, rash (15%), pruritus (27%), diarrhea (11%) and mouth ulceration (11%) were common adverse events.
Conclusions
This is the first report that aumolertinib has efficacy in patients with completely resected stage I-III EGFR mutated NSCLC with high-risk pathological factors. EGFR mutation positive as a poor prognosis factor was associated with higher recurrence than the negative or unknown.
Editorial acknowledgement
Medical writing support was provided by Hang Zhang, of Hansoh Pharma, Shanghai, China.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.